PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV issues.
Due to the relaunch of the EMA website in December 2023, you will find the current links to the entries prior to December 01, 2023 at https://www.ema.europa.eu
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Esomeprazole New
PSUR-outcome
|
16/01/2025
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
Cladribine (apart from products with multiple sclerosis indication) New
PSUR-outcome
|
16/01/2025
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
Bilastine New
PSUR-outcome
|
08/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Rivastigmine New
PSUR-outcome
|
07/01/2025
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
Chlorphenamine maleate / Paracetamol New
PSUR-outcome
|
07/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Lanthanum New
PSUR-outcome
|
07/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Oxycodone New
PSUR-outcome
|
07/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Sugammadex New
PSUR-outcome
|
19/12/2024
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
Terazosin
PSUR-outcome
|
27/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Mesalazine New
PSUR-outcome
|
25/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
